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June 5, 2017 OrthoSpineNews

June 1, 2017

DAYTON, Ohio – The Accelerant Venture Capital Fund recently approved investment in AMB Surgical to support the company’s development of a prototype for its Flyte Automated Growing Rod, a medical device that could revolutionize the way physicians treat juvenile scoliosis, lengthen limbs, and stabilize traumatic injuries.

The company founders bring decades of engineering experience to their work, as well as a personal mission to make such surgeries less traumatic for young patients.

Founder Casel Burnett would know. His daughter was diagnosed with juvenile scoliosis as a young child and endured years of invasive surgeries as part of the treatment. Scoliosis, or curvature of the spine, can lead to life-long health issues if not corrected while the child is still growing. Watching his daughter undergo treatment motivated him to find a better way.

“AMB embodies the innovative spirit and hard work that characterize the Dayton Region,” said Roger Edwards, Vice President of Accelerant Venture Capital Fund, an initiative of the Dayton Development Coalition. “Their work has the potential to revolutionize the way these conditions are treated and spare young patients repeated, invasive procedures.”

Burnett is a mechanical engineer and group manager of production engineering at Toyota, and partnered with friend Tyson Ross, an electrical controls engineer and program manager at the U.S. Air Force Research Laboratory, to see how they could take the existing technology and improve it. Ross and Burnett are confident they have found the answer.

AMB uses patented technology to electronically control the extension of rods used in orthopedic surgeries. Current devices use manual adjustments, either by having caretakers, such as parents, use tools to adjust an external framework for limb extension, or, for scoliosis, through repeated back surgeries. A physician implants an adjustable rod along the child’s spine, and as the child grows, uses tools to lengthen the rod through additional surgeries to correct the curve.

Flyte would allow the physician to expand the rod remotely, without surgery, as the child grows, both cutting down on the number of surgeries and potentially accelerating the treatment. It would eliminate the need for parents to adjust external frames, as well as reduce the likelihood of missing adjustments.

The key to their technology is tiny gear box located in the rod that has a microchip and RFID reader to program adjustments and record information.

Dr. Michael Albert, Director or Orthopaedics at Dayton Children’s Hospital, called the product a “game changer” in this type of treatment.

“We have made significant progress in the safety and design of limb lengthening external fixator devices, but what has been lacking is an automated, safe and reliable device that removes the patient or family from making daily adjustments,” Dr. Albert wrote in a letter of support for AMB.

Ross said they plan to develop a prototype with the current round of funding, starting with a rod that would be used in external frames, then moving on to implanted rods for scoliosis treatment and other internal uses.

For physicians, the device would also provide valuable feedback they can’t access today. The same technology that allows the device to adjust, allows it to collect data on the patient’s progress. The company already holds patents on the technology, and the initial research and design have generated interest from world leaders in pediatric orthopedic surgery.

“How small can we go? That’s the real question,” Ross said. “There’s tremendous potential for this type of technology, and we are confident we can bring it to market.”

The product would need to undergo testing and approval from the Federal Drug Administration.

The investment marks the 10th investment for Accelerant, the region’s only institutional VC fund with resources ready to invest in local companies. AMB has attracted significant “sidecar” investment as well, as private local investors find increasing opportunities to invest in start-ups in the Dayton Region.

“In the last year, we’ve seen a real shift in funding for local start-ups,” Edwards said. “The support and investment of local ‘angel investors’ is vital for start-ups to flourish. It’s exciting to connect local entrepreneurs to investors in the Dayton Region so they can grow their businesses here.”

AMB’s technology has generated interest from outside the Dayton region, as well. Dan Sands, a 25-year healthcare industry executive, has identified and is retaining world-renowned surgeon advisors, subject matter experts in engineering, accredited investment sources, and potential strategic commercialization entities.

“The positive market interest for this technology has been extraordinary,” said Sands, CEO of D11, LLC, who has spent most of his career in Warsaw, Ind., a city known within the industry as the “Orthopaedic Capital.” “Flyte’s ability to give surgeons real-time biomechanical stress/strain data will allow more accurate and timely remote non-surgical adjustments. This represents a game changing advancement in orthopaedics and could lead to a new frontier in bionic implantable devices that improves the total cost and quality of care.”

AMB plans to engage The Ohio State University’s Center for Design and Manufacturing Excellence and other expert resources as part of its efforts to develop the initial productionready prototypes. The Ohio State center plans to leverage its expertise to facilitate design feasibility, component and systems development, prototyping, manufacturing scale, and workforce development. “Working with Ohio State’s CDME brings resources and expertise to the process at an early stage that is difficult to find elsewhere in the country,” Ross said.

As for the young girl who inspired this technology, Burnett’s daughter Ashley Mae is all grown up, working as a nurse, and in great health. She’s the name behind AMB.

“We started down this path to help her, and I hope the work we’ve done will give children an easier journey than she had,” Burnett said. “We’re grateful for the support we’ve found here in Dayton and are excited to move forward with this opportunity.”

Dayton Development Coalition (DDC) is the leading economic development organization for the 14- county Dayton region. Working closely with public and private regional partners, its mission is to retain, expand and recruit jobs. The DDC and the Dayton region ranked as the nation’s top metro for its size for economic development in 2008, 2009 and 2012 and runner-up in 2010, 2011, 2014 and 2015. With the State’s largest single-site employer in its backyard, the DDC also focuses on advocating for the critical missions at Wright-Patterson Air Force Base and supporting the work of the United States Air Force. The DDC was ranked as America’s top military community, and was presented with the 2015 Community Excellence Award from the Association of Defense Communities. It was designated as one of the ADC’s Great American Defense Communities in 2016 – a testament to the collaborative efforts in support of Wright-Patt, America’s #1 Air Force Base as ranked by the Air Force Times (2014). For any questions regarding the DDC, contact Shannon Joyce Neal at (937) 723-2047. For more information on AMB, contact Dan Sands, 574-527-1525, or dan.sands@outlook.com.

For any questions regarding the DDC, contact Shannon Joyce Neal at (937) 723-2047. For more information on AMB, contact Dan Sands, 574-527-1525, or dan.sands@outlook.com.


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June 5, 2017 OrthoSpineNews

OR AKIVA, Israel, June 5, 2017 /PRNewswire/ —

Expanding Orthopedics Inc. (EOI), a privately-held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, today announced CE mark of the FLXfit™15, enhancing the already successful FLXfit™ 3D expandable cage. The FLXfit™15 expands up to 4mm and enables controlled lordosis correction of up to 15⁰. There are two linear length options; a 40mm and a 32mm version.

The higher range expansion will enable surgeons to better treat their patients and restore lordosis angle up to 15⁰. The 32mm length option will offer great flexibility in treating patients with smaller anatomies. The ability to deliver the largest, in-class, TLIF, expandable cage with 4mm height expansion and 15 degrees of lordosis correction through a small unilateral tube is a paradigm change in the MIS fusion market.

Ofer Bokobza, CEO of Expanding Orthopedics, commented “Expandable cages are gaining market momentum and play a key role in successful MIS fusion procedures. The FLXfit™ 3D expandable cage introduced a new paradigm with expandable cages and is already making a significant traction in the market place. We are thrilled with the release of the FLXfit™15 as it represents our continued commitment for innovation and ability to deliver state-of-the-art spine fusion solutions.” He concluded, “We believe that the versatility of the new FLXfit™ family will help EOI gain a greater share in the fusion surgery market both in MIS and open approaches.”

The FLXfit™15 is the subject of a pending 510k and is not available for sale in the US.

About Expanding Orthopedics Inc.

Expanding Orthopedics Inc. is medical device company developing and marketing innovative products designed to address unmet clinical needs for spine care and improve long-term patients’ outcome. The Company is spearheaded by a seasoned management team, and is advised by a prominent team of spine surgeons. EOI owns a broad patent portfolio around anatomically fit, expandable devices for enhanced stability through a minimally invasive approach.
Contact info:
David Elkaim, VP Marketing and Sales
E-mail: david@xortho.com
Phone: (347)-3219683

SOURCE Expanding Orthopedics Inc.


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June 5, 2017 OrthoSpineNews

Albany, NY — (SBWIRE) — 06/05/2017 — Interspinous spacers sometimes also called as Interspinous process decompression systems, are the devices implanted between vertebral spinous processes. These spacers are made up of a very strong but lightweight metal (titanium) which is biocompatible in the human body. These devices are imbedded in body to confine painful motion else enabling normal motion and to treat lumbar spinal stenosis, discogenic low-back pain, facet syndrome, disc herniations, and non-traumatic instability.

Lumbar spinal stenosis is a thinning of the spinal canal in the lower back which causes compression on nerves and it is developed gradually with age. Radiology tests are used to confirm a diagnosis of moderate degenerative lumbar spinal stenosis. People with lumbar spinal stenosis experience pain but may also have weakness in their leg, lower back and buttocks, numbness, tingling.

Obtain Report Details @ http://www.transparencymarketresearch.com/interspinous-spacer-market.html

The Interspinous spacer are implanted between those vertebrae in such a way that it prevents the patient from bending too far backward which causes pain by surgical procedure. The procedure is very small and sometimes patient can go home within a day.

The increasing prevalence of spinal stenosis due to aging, arthritis, heredity and increased demand of surgical procedures that improved lifestyle and comfort will drive the Interspinous spacer market. The adoption of spacers are increasing due to low complication rate as compared to decompression and spinal fusion. The Interspinous spacers are widely used in geriatric population as per Medicare data due to old age patient are not comfortable with surgery due to their health conditions.

The Interspinous spacer market is segmented as device type, end user and geography. The product type segment is further divided in two type’s statics or compressible and dynamic or non-compressible respectively. The examples of static devices include X STOP, ExtenSure and Wallis implants. These are made up of non-compressible material such as bone, metal or synthetics. The devices produce constant amount of distraction between the spinous processes due to their non-compressible nature. Dynamic Interspinous spacer devices have a degree of compressibility.

 

READ THE REST HERE


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June 2, 2017 OrthoSpineNews

SAN DIEGO, June 1, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced Skip Kiil is joining the Company as executive vice president, International. In this role, Mr. Kiil will oversee the Company’s international operations, reporting to NuVasive’s chairman and chief executive officer, Gregory T. Lucier, and serving on the Company’s executive leadership team.

Mr. Kiil brings to NuVasive more than 15 years of experience as a global medical technologies and life sciences business leader. He joins NuVasive from Alcon, a division of Novartis Corporation, where he most recently served as surgical head, Europe, Middle East, Africa and Russia.

“I am excited to welcome Skip as a member of the NuVasive executive leadership team,” said Mr. Lucier. “Skip has led complex, global commercial enterprises in Europe, the Middle East, Africa, Japan, Asia Pacific and the United States within the healthcare and spine technology industries. He brings significant strategic and operational expertise in market entry and development and proficiency in maintaining P&L responsibility, both of which are key elements as we scale and expand our high-growth international channels. We are pleased to have a global leader of Skip’s caliber join NuVasive’s world-class leadership team at this time as we accelerate past $1 billion in revenue, enhance our international operations and continue to change patients’ lives around the world.”

Mr. Kiil’s career includes extensive corporate experience in global markets. Prior to joining Alcon, Mr. Kill spent more than 12 years with Stryker Corporation, most recently as vice president and general manager, Medical Surgical Group, based in London and Rome. In that capacity, he was responsible for commercial operations for six strategic business units, including Neuro Spine/ENT, Surgical Instruments, Endoscopy, Sports Medicine and General Surgery/Visualization. Previously, as a senior leader at Stryker, Mr. Kill was general manager, MedSurg Japan, based in Tokyo. Prior to that, he had increasing corporate development, sales and marketing roles for Stryker in the United States. Mr. Kiil received a Bachelor of Science in Kinesiology from California State University, Fullerton and a Masters of Business Administration from University of Michigan.

NuVasive is the third largest global spine technology company with significant momentum to drive global growth and expansion as the Company seeks to double its international market share in the coming years. NuVasive is targeting international revenue growth at 20 percent or higher annually and scaling international operations to support the Company’s profitability expansion goals. The Company’s share-taking strategy and innovative product introductions drove growth across all of its international geographies including Europe, the Middle East, Asia Pacific and Latin America in the first quarter of 2017, leading to a 34% year-over-year increase on a reported basis in international revenues, excluding the impact of currency.

About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries around the world. For more information, please visit www.nuvasive.com.

Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com


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June 2, 2017 OrthoSpineNews
Warren, NJ, June 01, 2017 –(PR.com)– NJ-based Prosidyan (www.prosidyan.com), developer of proprietary fiber-based bioactive glass products, announced today that it has received FDA 510(k) clearance of FIBERGRAFT BG Putty – Bone Graft Substitute for Postero-lateral Spinal Fusion. FIBERGRAFT BG Putty is the second generation product in the company’s FIBERGRAFT line of bioactive glass based products. FIBERGRAFT BG Putty leverages the direct connectivity of fibers with an exponentially increased surface area and optimized resorption rates delivered using Prosidyan’s proprietary bioactive carrier, OSSIGLIDE.

FIBERGRAFT BG Putty – Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT BG Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., posterolateral spine, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT BG Putty must be used with autograft in the posterolateral spine. FIBERGRAFT BG Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

Dr. Babak Barcohana MD of the Southern California Orthopedic Institute commented, “I have had outstanding clinical results with FIBERGRAFT BG Morsels over the last three years and look forward to continued clinical success with this next generation product from Prosidyan.”

Dr. Stephen Tolhurst MD of the Texas Back Institute commented, “FIBERGRAFT BG Putty is backed by great science and pre-clinical results. It is the only synthetic bone graft I feel comfortable using without mixing with bone marrow aspirate, making it easy to use in surgery.”

Dr. Brian Kwon MD from New England Baptist Hospital called FIBERGRAFT BG Putty “The most intelligent bone graft on the market and your best bone graft decision in the OR.”

Prosidyan was founded in 2009 to develop a family of synthetic bioactive bone graft substitutes based on microscopic fibers of bioactive glass. Prosidyan’s first product, FIBERGRAFT BG Morsels, a synthetic bone graft substitute, received FDA clearance in March 2014, and the first surgery utilizing this innovative bone substitute was performed in May 2014. The firm’s second product in the line, FIBERGRAFT BG Putty, received FDA clearance in March 2015, and comprises FIBERGRAFT BG Morsels delivered through Prosidyan’s proprietary bioactive carrier, OSSIGLIDE. To date, FIBERGRAFT products have been implanted in over 7,000 patients across the U.S. Prosidyan is poised to revolutionize synthetic bioactive bone graft options, with numerous patents and a robust pipeline of products in late stages of development.

Distribution Opportunities are still available. Contact Sales@prosidyan.com

About Prosidyan: Prosidyan is the creator and supplier of the next generation in synthetic bone grafting through its proprietary manufacturing process utilizing microscopic fibers of bioactive glass. For more information about the company and its products, please visit www.prosidyan.com, or call 908.517.3666.

Contact Information
Prosidyan, Inc.
Charanpreet S. Bagga
(908)-517-3666
Contact
www.prosidyan.com

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June 1, 2017 OrthoSpineNews

Carolyn LaWell – May 2017

EPOSNA 2017, the combined annual meeting of the European Paediatric Orthopaedic Society and Pediatric Orthopaedic Society of North America, served as an unveiling for new products, brands and companies as a focus on this niche market is drawing in device companies.

Two dozen device, bracing and pharmaceutical companies exhibited at EPOSNA in early May. The way Nick A. Deeter tells it, a decade ago there were three at the North American meeting: OrthoPediatrics (the company that Deeter founded in 2006), Biomet and Smith & Nephew. Attending EPOSNA with WishBone Medical, the pediatric company he founded earlier this year, Deeter said that he believes the pediatric segment is ripe for growth. For one, there is demand. WishBone estimates the market at $1.4 billion, growing at 10% per year. Two, it is one of the few areas in orthopaedics that has yet to gain attention from device companies—though our tracking of announcements in the space suggests that could be changing.

Here’s what’s happened just since 4Q16:

  • Implanet received global regulatory clearance for Jazz Frame connectors for use with the JAZZ Band in the treatment of adult and pediatric spinal deformity.
  • Materialise gained FDA clearance for Surgicase Orthopaedics to assist in pre-op planning for pediatric patients undergoing radius and ulna osteotomies.
  • Medicrea received FDA clearance of specialized posterior fixation and band connector components.
  • Mighty Oak Medical obtained FDA clearance for 3D-printed FIREFLY Pedicle Screw Navigation Guides, reported to be the only patient-specific pedicle screw guide indicated for use in pediatric patients.
  • NuVasive announced that it’s building up a salesforce for exclusive focus on pediatrics to promote its MAGEC rod for early onset scoliosis and PRECICE technology for limb lengthening.
  • Onkos Surgical, focused on the adult and pediatric surgical oncology market, received its first FDA 510(k) for the Eleos Limb Salvage System.
  • Orthofix launched JuniOrtho, a new brand to house services (apps, games, education tools) and products that treat pediatric orthopaedic and congenital deformities, including the TL HEX TrueLok Hexapod system and Guided Growth plates.
  • OrthoPediatrics, a solely-focused pediatric ortho company, launched a new distal femoral osteotomy system.
  • WishBone Medical formed and announced planned launch of single use, disposable implants and instruments for foot and ankle, trauma, spine and sports medicine indications.

 

READ THE REST HERE


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June 1, 2017 OrthoSpineNews

 – May 22, 2017

SAN DIEGO, CA – May 22, 2017 – NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the Company’s increased investment and support of adult and pediatric deformity research, education, and awareness initiatives throughout 2017.

NuVasive increased its focus on the $2.5 billion deformity market in May 2015 with the launch of its Integrated Global Alignment® (iGA®) platform and RELINE® posterior fixation system. In February 2016, NuVasive expanded its footprint into the early onset scoliosis market with the addition of its industryleading MAGEC® system, which utilizes innovative magnetic technology within adjustable growing rods. Today, NuVasive has the fastest growing spinal deformity portfolio and is expanding its support of key programs to drive improved clinical and economic outcomes. NuVasive recently launched the ‘Embracing the Journey Together’ program, which includes pediatric spinal deformity research, education and spinal deformity event support, supporting leading surgeons as they educate surgeons around the world.

“At NuVasive, we remain laser-focused on transforming the lives of patients through disruptive innovation and support of clinical education and research,” said Greg Lucier, NuVasive chairman and chief executive officer. “We’ve made tremendous gains in adult and pediatric spinal deformity innovation, with the versatile RELINE portfolio and MAGEC system. With the upcoming launch of the RELINE Small Stature system available this summer, I’m confident in our ability to outpace the market. We’re proud NuVasive has taken the lead in supporting key global initiatives designed to help improve the lives of patients around the world.”

 

READ THE REST HERE


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June 1, 2017 OrthoSpineNews

May 31, 2017

Paxeon Reconstruction, a manufacturer of best-in-class orthopedic products including derivative and emerging products, announces the promotion of Kyle Sineath to President. Prior to this appointment, Mr. Sineath served as Vice President of Global Sales for Paxeon. Mr. Sineath joined Paxeon after 10 years in the medical technology and orthopaedics industry, where he held a number of senior level leadership roles at Amedica and most recently, Vice President of Sales for NuTech Medical. Mr. Sineath holds a duel Bachelor of Science from the University of Pikeville.

“The orthopedics market has changed dramatically over the past 10 years and I am thrilled to be in a position to bring new products and creative ideas that further assist our surgeons deliver the best possible outcomes for patients around the world.” Said Mr. Sineath.

In addition to this appointment, Mr. Sineath has been asked to participate as a panelist at the upcoming Becker’s 15th Annual Spine, Orthopedic and Pain Management-Driven ASC Conference + The Future of Spine on June 22-24, 2017 in Chicago, IL.

With keynote speakers Andrew Hayek (Chief Executive Officer of Optum Health and Surgical Care Affiliates), Michael Kasper (Chief Executive Officer of DuPage Medical), Lou Dobbs (Fox News) and Marcus Allen (Former NFL Running Back and Member of the NFL Hall of Fame), this conference includes more than 1,100 Attendees at this World-class ASC Event Focused on Orthopedics, Spine and Pain.

In the session titled “Investing in Early Stage Spine and Device Companies – Smart? Dumb? and Practical Advice”, Mr. Sineath will be joined by President and CEO of AngelMD, Tobin Arthur, as well as President and CEO of Life Spine, Michael Butler. The session will be moderated by John Harig, JD.

______

About Paxeon Reconstruction

Paxeon Reconstruction builds best-in-class orthopaedic products, including derivative and emerging products. We collaborate with hospitals, health systems and physicians to create alignment and utilization of value-based solutions combined with efficiency models for today’s changing healthcare environment. Paxeon Reconstruction offer the world’s most comprehensive portfolio of orthopaedic products and services for joint reconstruction. Paxeon Reconstruction has a celebrated clinical history, and has evolved to meet the needs of the changing orthopaedics marketplace. The history that weaves the fabric of the Paxeon Reconstruction is one that is rich with innovation and demonstrates sustained leadership in an ever-changing landscape of patient and professional needs.

 


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May 31, 2017 OrthoSpineNews

CARLSBAD, CALIFORNIA–(Marketwired – May 31, 2017) – Aurora Spine Corporation (TSX VENTURE:ASG) announced today that the company has selected its proprietary implant locking technology covered by United States Patent No.: 9,603,637 entitled “POLYAXIAL INTERSPINOUS FUSION IMPLANT AND BONE GROWTH STIMULATION SYSTEM” for out-licensing opportunities for medical and industrial applications.

“Aurora Spine is now offering its new Polyaxial ZIP® Interspinous device patent for out-licensing or private label opportunities. The combination of the proven ONE-STEP™ locking mechanism, with no setscrew, and the polyaxial feature could be a unique opportunity in new product development for orthopedic and other medical and industrial manufacturers,” said co-inventor, Trent Northcutt, President and CEO of Aurora Spine.

“Aurora’s patented features offer new design directions for hardware connections that do not rely on conventional threads and screws thus preventing hardware loosening related problems,” said Laszlo Garamszegi, Chief Technology Officer of Aurora Spine.

For more information on out-licensing or private label opportunities using the Polyaxial ZIP ISP platform, contact Laszlo Garamszegi at 760-424-2004 or info@auroraspine.us.

About Aurora Spine

Aurora Spine is an early stage company focused on bringing new solutions to the spinal implant market through a series of screwless, innovative, minimally invasive, regenerative spinal implant technologies. Aurora Spine continues to position itself at the forefront of spinal surgery procedures, focusing on minimally invasive spine surgery technologies. Aurora Spine is changing spine surgery by focusing on disruptive technologies following the Company’s commitment to – Simplifying the Complex.

Forward-Looking Statements

This news release contains forward-looking information that involves substantial known and unknown risks and uncertainties, most of which are beyond the control of Aurora Spine, including, without limitation, those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Information” in Aurora Spine’s final prospectus (collectively, “forward-looking information”). Forward-looking information in this news release includes information concerning the proposed use and success of the company’s products in surgical procedures. Aurora Spine cautions investors of Aurora Spine’s securities about important factors that could cause Aurora Spine’s actual results to differ materially from those projected in any forward-looking statements included in this news release. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ unilaterally from those expressed in such forward-looking statements. No assurance can be given that the expectations set out herein will prove to be correct and, accordingly, prospective investors should not place undue reliance on these forward looking statements. These statements speak only as of the date of this press release and Aurora Spine does not assume any obligation to update or revise them to reflect new events or circumstances.

 

CONTACT INFORMATION

  • Aurora Spine Corporation
    Trent Northcutt
    President and Chief Executive Officer
    (760) 424-2004

    Laszlo Garamszegi
    Chief Technology Officer
    (760) 424-2004
    www.aurora-spine.com


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May 31, 2017 OrthoSpineNews

Published on

The orthopedic industry is changing faster than ever before. Whether you’re a surgeon, sales rep or orthopedic patient, much of the impact is less than positive. It seems that the industry is piling on the sales rep in an effort to marginalize and some might say eliminate the rep altogether. I recently read a headline about HCA’s record quarterly profits topping $980 MILLION. Keep in mind that this was Q4, 2016 at a time when hospitals are crying poor while fighting orthopedic companies on pricing like never before. Gone are the days where it was customary to assess a 3% price increase tied to the Consumer Price Index (CPI) each year. Now as a rule, hospitals and GPO’s are forcing prices to new lows year over year and even seem willing to sacrifice the presence of the rep in the operating room. It is impossible to argue the point that the orthopedic sales rep is being marginalized. In recent years, they have been told by various constituents that they are a “non-essential” part of the healthcare continuum. In an effort to increase profits, not only are these hospitals and GPO’s fighting to bring down prices, but they also seem to be fighting over the remaining piece of the pie belonging to the sales rep by way of confiscating their commissions. But are sales reps expendable? Do they only add cost to the continuum as some suggest?

If reps are eliminated from the picture, who will step in to bear the burden of support that surgeons are accustomed to receiving from their sales reps? Are surgeons going to be expected to hire P.A.’s to fill in the void of what the reps currently do? Does anyone really grasp the full picture of what the orthopedic rep does and value they bring to the healthcare system? Let me try to give you a former sales rep’s perspective on the value of the orthopedic sales rep.

A historical perspective

When I started as a sales rep for Zimmer in the orthopedic industry 30 years ago, it was evident to me that being a rep afforded me the privilege of being an integral part of the surgical team to ensure the most optimal surgical outcomes for the orthopedic patient. There was a level of trust, camaraderie and appreciation that made the role extremely rewarding. Reps like myself felt appreciated because it was evident that surgical teams wanted us in the room during cases because of the unique value we brought to the case. Ours was a special role of supporting both the surgeons as well as the hospital’s support staff. Whether we were an extra set of hands to hold the patient’s leg during prep or opening that sterile peel pack when someone dropped a disposable suction tip when the circulator was preoccupied, we stepped in to do whatever we could to keep the case progressing without a delay. Having a rep in the room was an obvious value to all because we possessed a unique perspective and skill set. We were the ones with experience in those unfortunate scenarios when things did not go just like they are supposed to in the technical video. On the infrequent occasion of a surgical complication, the reps are typically leaned on for their expertise. They help the surgeon troubleshoot during the procedure to bring about an optimal successful outcome. In many cases, the rep is the person with the most diverse experience with the products and procedure even if only by observation. Countless times, I was leaned on by the surgeon to solve a complex challenge that arose either out of some unexpected pathology or a complication. I was the one who witnessed thousands of procedures encountering far more complications and variables than the scrub tech, assistant or the surgeon. I was the one with the broadest experience to walk them through how to resolve it in such a way as to bring about the best result. In extreme cases, observers said that watching a good sales rep in surgery was often like seeing the sales rep “conduct surgery through remote control.” I was accustomed to it and considered it a privilege to ensure my surgeon’s patient had the best possible result. This kind of support is an everyday routine for many sales reps in O.R.s around the world. Before my time, I heard stories from reps that actually scrubbed in and held retractors, and in some cases doing far more of the procedure than anyone would expect until finally someone got into deep trouble. There was a book written about it called, “Salesman Surgeon” that recounts a situation where the surgeon was not even in the room when some cases were being done.

We are a long way away from that, and that is a very good thing. However, there are very real benefits as a result of having reps participate in the O.R. I am convinced that there are profound benefits to the hospital, surgeon, staff and patient.

1. Better Patient Outcomes

2. Time Savings

3. Cost Savings

These merely represent the value of the rep in the room. However, there is great value to healthcare beyond having an orthopedic sales rep present during surgery. In fact, it is what leads up to the surgical theater that is often overlooked and without a talented rep, a void will be created that must be filled by someone. It was always gratifying to me the appreciation that I received from nurses and administrators. However, I remember showing up to sell in my new territory at an O.R. in Lancaster, CA to introduce myself as the new Zimmer rep back in 1989. I entered the O.R., while staying behind the line, and asked the gal at the desk if I could speak with the O.R. Supervisor. She gave me a long up and down look then proceeded to speak into the microphone to the overhead intercom to announce my arrival. “Jennifer, there’s a gentleman with tassels on his shoes at the desk waiting to see you.” That is how some people see reps. Just well dressed people who waltz in and expect to have the red carpet to sell people stuff. In reality, reps spend a ton of time meeting with surgeons to help them with preoperative planning, reviewing x-rays to ensure that they are ready for anything when the patient is under anesthesia. It is the job of a rep to be 100% certain that you have everything you need for the case which may require flying equipment in from cross country, but not having it is never an option.

It seems overlooked that sales reps, especially those who cover trauma, are on the clock 24/7 in support of their surgeon and hospital clients. It might seem like no big deal to those who don’t understand the implications, but imagine for a moment that you are a sales rep and you have 20 surgeons you support, each with their own individual schedule and demands. It is a balancing act like no other to support the needs of these surgeons and their patients. Not showing up or having the equipment ready for a case is never an option, and certainly would result in risking losing business and tarnishing your reputation. There are always competitors standing in lurch waiting for someone to mess up. I always said that for every surgeon who uses a product, there is a rep “on deck” waiting for their chance to save the day when you screw up.

Another reality for many reps is never taking a family vacation that wasn’t somehow tied to a business event. In my day, not only did I have to pay my own way but also those of some of my surgeon customers and their families. It wasn’t so much about getting new business as it was about protecting your business. The expectation was that since they used my products and I benefitted from it, I would cover the major expenses of their trip to get CME credits. The risk was that if I did not, one of my competitors would entice them to go to one of their meetings and they may come home and switch.

The industry has changed in some positive ways as well. When I was the Zimmer rep, I covered everything from Recon to Trauma. This meant that I could easily be in surgery all day on Monday, get a trauma case in the evening requiring me to be there all night, and not make it home before my 7:30AM case the next morning. When I was on call, I could be at dinner or a movie with my wife and suddenly have to run her home to run sets and cover a case. Sunday mornings looked like driving to church in separate cars in case the pager went off and I had to leave on the spur of the moment.

The point I’m making is that in a very real sense, many sales reps have the insane schedule of a surgeon with many similar time demands, and yet without some of the upside. It is also the rep that enables surgeons to make quick decisions about treatment of a patient and they know their rep will take care of getting everything they need to fix the patient. It may be as simple as calling the office and having it delivered or more complex as having to drive across town to borrow it from another hospital or distributor, or even times when you have to contact someone out of state and have equipment flown cargo on a commercial airline to get there in time. The reality is that most of the stressful things that happen never see the light of day and no one in the hospital is aware of the extreme measures taken in order to see to it that the patient got the very best treatment.

It is unclear to me who will be there to step into the gap and support the orthopedic surgeon if the rep is tossed to the side. I think we always expected that over time the market would force out the more skilled and experienced orthopedic reps in favor of cheap labor, similar to a pharma rep. Our saving grace was always that they didn’t like to work that hard. Perhaps the time has come that the market will shift the reps support responsibilities on to the surgeons who will undoubtedly need to hire someone to support them. Maybe the market simply needs to see what it looks like to force the best and brightest out and see the impact on the surgical teams. One thing is for sure, the market seems to behave like they see reps as unnecessary. Time will tell.

Drue De Angelis

CEO, Surg.io LLC

Surg.io is the total orthopedic distributor/rep solution to go from working “in” your business, to working “on” it. A simple software solution that adapts to your workflow enabling greater communication, accuracy and efficiency. Surg.io saves time and money. It’s like having an extra person on the team. /Surg.io

 

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